Actively Recruiting

Phase Not Applicable
Age: 5Years - 8Years
All Genders
ID06798090

Evaluation of Clinical Success and Changes in Periodontal Tissues of Band-Loop Space Maintainers Produced With Three-Dimensional Printer and Conventional Technique

Led by Aydin Adnan Menderes University · Updated on 2025-01-29

27

Participants Needed

1

Research Sites

N/A

Total Duration

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AI-Summary

What this Trial Is About

Researchers are conducting a randomized clinical trial to compare the clinical success and effects on periodontal tissues of band and loop space maintainers made with a three-dimensional printer versus those made by conventional methods. The study focuses on systemically healthy children who require bilateral lower deciduous first molar extraction and space maintainer application. The goal is to assess how these two types of space maintainers perform and affect gum health over time. The trial uses a split-mouth design where each child receives a band and loop space maintainer made by conventional technique on one side of the lower jaw and one made by a three-dimensional printer on the other side. Digital impressions will be taken with an intraoral scanner, and the 3D-printed space maintainer will be created using micro laser sinterisation from nickel-chromium metal powders. The conventional space maintainer will be made with traditional alginate impressions and stainless steel bands soldered in a laboratory. Participants will be followed for 18 months with check-ups every six months to monitor the survival and clinical success of each appliance, including criteria like cement dissolution, breakage, gum inflammation, and plaque buildup. Periodontal health will be evaluated through pocket depth, plaque index, gingival index, and tests of gingival groove fluid for inflammatory markers. Patient satisfaction with the impression methods will also be compared. Assessments will be repeated at baseline and during follow-up visits to understand the long-term effects of the space maintainers.

CONDITIONS

Brief Title

Evaluation of Band-Loop Space Maintainers Produced With Three-Dimensional Printer and Conventional Technique

Who Can Participate

Age: 5Years - 8Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Systemically healthy children
  • Bilateral early loss of deciduous first molar teeth in the lower jaw
  • Radiographically confirmed permanent tooth germ under the extracted deciduous tooth
  • Radiographically determined minimum 1.5 mm bone above the permanent tooth germ
  • Presence of flush terminal plane or mesial step in deciduous dentition and Angle class 1 molar relationship in mixed dentition
  • Radiographically and clinically healthy abutment teeth
  • Frankl behavior rating score of 3 or 4
Not Eligible

You will not qualify if you...

  • Patients with systemic diseases
  • Frankl behavior rating score of 1 or 2

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit (in-person)

Implementation

Duration - Up to 18 months

Participants will receive two types of band and loop space maintainers on opposite sides of the lower jaw: one produced with a three-dimensional printer and the other produced by conventional technique.

Follow-up visits every 6 months for up to 18 months

Long-term Monitoring

Duration - Up to 18 months

Participants will be monitored for clinical success and changes in periodontal tissues using pocket depth, plaque index, gingival index, and gingival groove fluid examinations.

Assessments at baseline and at 6-month intervals during follow-up visits

Trial Site Locations

Total: 1 location

1

Aydın Adnan Menderes University

Aydin, Aydın, Turkey (Türkiye), 09100

Actively Recruiting

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Research Team

S

Sultan Keles, Associate Proffesor

Ö

Özgün Öztürk

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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